Steven Eaton, a UK scientist who cooked experiments while at the U.S.-based contract research outfit Aptuit, has been given a three-month prison term, making him the first person to serve time under a 1999 British law called the Good Laboratory Practice Regulations, according to the BBC.

As the BBC reported:

Eaton, 47, was working at the Edinburgh branch of US pharmaceutical firm Aptuit in 2009 when he came up with the scam.

If it had been successful, cancer patients who took the drug could have been harmed, the court was told.

Edinburgh Sheriff Court heard how Eaton had manipulated the results of an experiment so it was deemed successful when it had actually failed.

He had been manipulating his results since 2003, it seems, including tests for compounds from Roche and AstraZeneca. These included a variety of drugs, from anti-cancer agents to anti-depressants, according to the Financial Times, via Fierce Biotech.

We haven’t found any publications on which Eaton was an author, but that doesn’t mean they don’t exist.

In light of the inquiries we have received following the MHRA’s recent press release relating to its investigation of the bioanalytical group at our former Riccarton, Scotland site, Aptuit wants to clarify information related to the MHRA’s prosecution of a former employee, Steven Eaton. Mr. Eaton was recently found guilty by Edinburgh Sherriff’s Court for altering pre-clinical trial data at our Riccarton site. Here are the details:

In February of 2009, a supervisor at Aptuit Riccarton identified irregularities in some of Mr. Eaton’s bioanalytical data as part of the company’s Quality Control Procedures. Aptuit representatives promptly notified the MHRA and, based on that notification, an investigation was initiated. It was determined that the irregularities in the work of Mr. Eaton began as early as 2001, when the Riccarton site was owned by Quintiles. Aptuit acquired the Riccarton site from a subsidiary of Quintiles Transnational Corp. in late 2005.

In accordance with Aptuit corporate policies, Mr. Eaton’s actions resulted in immediate disciplinary procedures and his prompt departure from Aptuit’s employment. Mr. Eaton has not been associated with Aptuit for more than four years.

Aptuit fully supported and cooperated with the MHRA during the 2-1/2 year investigation and undertook study-by-study impact assessments of Mr. Eaton’s actions. Aptuit also took corrective and preventative actions, while openly communicating and cooperating with customers.

It is important to note that the MHRA stated in its March 12th press release that “following a full assessment by the MHRA’s inspection team and assessors it was concluded that the data integrity issues did not invalidate the results of the clinical trials that were affected.”

At the close of this investigation two years ago, Aptuit received a letter from the MHRA stating that the matter was concluded and that “…the investigation by the MHRA and GLPMA has found no evidence to suggest that the data integrity issues were caused as a result of actions taken by the company. The data integrity issues appear to have been caused by the independent actions of individual employees.”

GLP certification at the Riccarton facility was maintained throughout the period of this MHRA investigation. Subsequent audits conducted by the MHRA also resulted in the continued GLP certification.

Aptuit implemented a comprehensive corrective action/preventative action (CAPA) program to address and correct the situation. All impacted customers were engaged in the process to ensure minimal impact to their ongoing projects. The CAPA program included the development and institution of new or updated SOPs and quality programs, as well as additional training for all staff.

All customers with impacted studies were contacted by Aptuit and kept informed as the impact assessments were carried out during the period from February 2009 to December 2010. If a customer was not contacted during this time, it was not impacted.

Aptuit closed its Riccarton site in 2011 due to business reasons unrelated to the MHRA’s investigation, and no longer conducts any activities for customers at the site. As an industry leader in drug discovery and development services, Aptuit recognizes the importance of data integrity and remains committed to delivering the highest quality of data and services to its clients. Aptuit reiterates that the MHRA investigation was concluded years ago at a former site and has no effect on current operations.

Very few researchers have served jail time for scientific misconduct. Scott Reuben was sentenced to six months’ prison for health care fraud and Eric Poehlman got a year and a day for faking a grant application. Luk Van Parijs was given six months of home detention and 400 hours of community service for fraud in papers.

Why? The submission of false data in a grant application to a governmental agency is considered fraud, a Federal crime, punishable by jail and/or fine. Certainly more than three investigators have done so in grants worth significant amounts of money..

I assume if a construction company had received a million dollar contract from the Federal government for a project which was later found to have not met the specifications, it would be prosecuted..

I believe that the threat of such Federal prosecutions of scientists for misconduct would have a deterrent effect. ORI does not have prosecutory power but it can forward cases to the Justice Department.

For over one year now I repeat on Retraction Watch that IT’S TIME TO OUTLAW ACADEMIC/PUBLICATION FRAUD!

Jail and/or hefty fines should be extended also to editors/publishers/institutions who, instead of Doing_the_Right_Thing in cases of obvious and straightforward misconduct, actively do cover up the fraudulent authors, thus become associates in conspiracy to obtain public money by deception.

As I have suggested on RW, it’s time to establish within FBI a department to deal with Academic Fraud. This will save every year hundreds of millions (even billions) of tax-payers’ dollars which can be better used, especially now in time of austerity. It will be highly efficient as well – just set up a website for tip-offs and offer a symbolic reward for providing information which proves the fraud. All the evidence is out there (i.e. in the publications/submissions, etc.) accessible for everyone and can not be destroyed, for bad luck of the fraudsters.

This will be beneficial for everyone: for all hard-working tax payers; for all honest researchers, reviewers, editors, publishers; for all users of peer reviewed publications, and in long-term even for the potential offenders as well.

I imagine that it would be very difficult to prosecute a criminal case of fraud for a federal research grant as it would be tough as nails to try to determine how much financial damage can be attributed to the actual misconduct. For instance, if it takes only one hour for a grad assistant to fudge his data, and he only makes $15/hour, this would hardly be seen as a felony. I’m aware that this sounds like a silly statement, but this is exactly what a defense attorney would argue.

In the instance of outright financial fraud, I believe ORI forwards the cases to the Inspector General, which is the essentiallyt the FBI for the Department of Health.

The offender should reimburse all the damages incurred by other researchers who used his/her fake data, pay for the time spent on review and pay all the costs paid by universities to publishers. It’s about time we all stood together to kick fraudsters out of Academia.

Couldn’t agree more. The current system is fundamentally flawed — it creates incentives for multiple misconduct while at the same time does nothing to deter offenders and/or to rectify the situation. In most cases all what editors/publishers/institutions (and even COPE) do is a COVER UP. They should be held accountable for not Doing_the_Right_Thing when evidence is presented. (imagine for a moment what will happen should the same approach is applied to road traffic) IT’S TIME FOR A CHANGE OF THE SYSTEM!!!

You are correct, Joel, it is difficult to determine how much of the federal funding for the research was actually affected by or resulted from the research misconduct. In my 17 years as a chief reseach fraud investigator for OSI/ORI, we consulted with the NIH financial and program officers after many ORI findings, as to whether they would pursue recovery of funds from the institution for fraudulent research work on NIH grants. In one case where they proposed it, the perpetrator was actually able to prove that none of the work was done on his NIH grant (he had only cited in the frauduent paper, but never actually used NIH money on it). In other cases, the misconduct is a very small part of the actual research and effort (as you noted), so the proportion of recover would be trivial. Furthermore, federal grants are “assistance” (unlike contracts, whiich require a specific output), and some/many federal grants produce little useful outcomes — they may have done the proposed work, but the result was negative or not significant), and no recovery is sought.

In addition, it is the federal Department of Justice with the agency Office of Inspector General [not ORI] that has to pursue the criminal or civil prosecution for False Claims Act and related fraud. In my experience, they do not consider prosecuting a case that would not recover a couple hundred thousand dollars, as it is not worth all the staff and attorney time prosecute for lesser amounts. Nonetheless, as I noted earlier (see below), there have been a few federal prosecutions leading to prison sentences for research fraud in ORI cases.

That’s not too hard to figure out. He worked for the CRO and the CRO worked for the drug company. Some of these CROs have been so blatant as to take a variable fee based on the eventual sales of the product! See Quintiles and Cymbalta. So, um, do you think the CRO in that situation might have a certain, um, incentive to deliver positive results? No matter what the data say? That’s the magic of the marketplace in action.

One of the best ways to HARM a Pharmaceutical company would be to falsify data to lure them into running expensive trials doomed to failure.

To my knowledge, there is no evidence that either the study sponsors or Aptuit as an organization had anything to do with Eaton’s actions. The simplest explanation is that he was either too lazy, incompetent, or (as mentioned above) overworked to complete and report valid assay data, so he made up some numbers. Either way, he has a few months to think about it.

I’ve been trying to figure this out. I spoke to the MHRA for Chemistry World, (http://www.rsc.org/chemistryworld/2013/03/aptuit-former-researcher-guilty-clinical-data-tampering) who gave me the impression that he was too lazy/incompetent to set up his machine properly, but ultimately conceded that they didn’t know. But other sources point out that GLP requires regular audits. This went on for 6 YEARS. How did Aptuit (and Quintiles before them) not pick this up earlier, if they were fulfilling their legal auditing responsibility? And how did they avoid prosecution themselves? Plus, in another interesting development, the Scottish courts at this level appear not to keep case records, so that makes it harder to dig out the details.

None of this was actually enforced in the US until about 2002. From 1997-2003 it was virtually impossible to get CFR 21 p11 compliant lab instruments because, in the absence of enforcement, nobody bothered to make them. This changed almost overnight when the FDA issued a few 483’s that shut down large GMP plants. In theory, people in my lab could have been altering data. If they were clever enough, we’d have never known.

While I understand the attitude of those who cheer the jailing of scientific cheats; surely as deserving as jail as small scale drug dealing, in my view the downsides outweigh any minor satisfactions. Namely it is almost impossible to get anyone other than the occasional undergraduate caught cut and pasting from wikipedia by University authorities, so I don’t imagine that the idea that a professor might end up in jail would do anything other than make their pretenses of investigations even more inadequate than the are at present. It would also impose an intolerable burden on whistleblowers.

The ORI has the authority to forward cases to the Attorney General for prosecution. They then decide if they want to pursue it. I don’t know how often such referrals are made.. My hunch is, not often enough.

ORI discusses its cases with the Office of Inspector General at HHS, which can make referrals to the U.S. Attorneys in the Department of Justice (DoJ). The DoJ AUSAs also ask ORI for help in asssessing and investigating allegations of grant fraud in qui tam suits filed by relators (whistleblowers) to DoJ.

– – – – – – Another ORI / DoJ case with prison time was in 2006: Mr. Paul Kornak, Clinical Research Coordinator at the Stratton New York Veterans Administration Medical Center, falsely claimed to be an M.D. and falsified clinical trial data, including that to enroll an ineligible veteran patient, who died from the treatment? DoJ found negligent homocide with a 6 year prison term, and ORI debarred him for life.

Of the 48 criminal charges contained in his Indictment, Paul Kornak pled guilty to the three criminal charges listed above. See United States of America v. Paul H. Kornak, Criminal Action No. 03-CR-436 (FJS), U.S. District Court (N.D.N.Y.) (January 18, 2005). In addition to the 71-month term of imprisonment imposed, Mr. Kornak was directed to pay restitution to two pharmaceutical companies and the VA in the amount of approximately $639,000.